不同生化血清非定值质控品性能的应用评估  

The performance evaluation of unassayed biochemistry serum controls

作　　者：刘瑞来[1] 张晨 林炜炜[3] 丁慧[4] 关明[1,2] Liu Ruilai;Zhang Chen;Lin Weiwei;Ding Hui;Guan Ming(Department of Clinical Laboratory,Huashan Hospital,Fudan University,Shanghai 200040,China;Department of Clinical Laboratory,Huashan Hospital North,Fudan University,Shanghai 201907,China;Department of Clinical Laboratory,Renji Hospital,Shanghai Jiaotong University School Of Medicine,Shanghai 200090,China;Department of Clinical Laboratory,Tongren Hospital,Shanghai Jiaotong University School Of Medicine,Shanghai 200336,China)

机构地区：[1]复旦大学附属华山医院检验科,上海200040 [2]复旦大学附属华山医院北院检验科,上海201907 [3]上海交通大学医学院附属仁济医院检验科,上海200090 [4]上海交通大学医学院附属同仁医院检验科,上海200336

出　　处：《中华检验医学杂志》2019年第9期787-792,共6页Chinese Journal of Laboratory Medicine

摘　　要：目的探讨不同生化血清非定值质控品的瓶间差、开瓶稳定性及互换性。方法于2016年5月在检验科分别对Pretrol?生化非定值质控品与伯乐生化非定值质控品进行了比对相关检测。瓶间差是连续测定多瓶质控品结果的批间不精密度,并剔除同一瓶质控品连续测定结果的批内不精密度,计算质控品的瓶间差。开瓶稳定性是按厂商说明书要求复溶,并分别计算在2~8℃条件下保存7d,及在-20℃条件下保存30d的不精密度。互换性是计算不同质控品间在不同仪器上的同一个项目的不精密度。结果Pretrol?生化非定值质控品中,常规生化13个评估项目的瓶间不精密度(CV浓度1/CV浓度2)分别为钾(0.26%/0.42%)、钠(0.26%/0.21%)、磷(0.00%/0.62%)、胆固醇(0.56%/0.54%)、总蛋白(0.52%/0.33%)、白蛋白(0.44%/2.00%)、谷丙转氨酶(1.72%/0.57%)、γ-谷氨酰氨基转移酶(0.52%/0.62%)、谷草转氨酶(3.10%/1.09%)、乳酸脱氢酶(0.76%/0.91%)、碱性磷酸酶(1.13%/0.97%)、淀粉酶(0.30%/0.39%)和葡萄糖(0.00%/0.40%),均符合临床生物化学检验常规项目分析质量指标(WS/T403-2012)内规定的CV%要求;常规生化13个评估项目,在2~8℃条件下保存7d及在-20℃条件下保存30d的不精密度(保存在2~8℃条件下的CV浓度1/CV浓度2;保存在-20℃条件下的CV浓度1/CV浓度2)分别为钾(1.06%/0.36%;0.74%/0.48%)、钠(0.49%/0.59%;0.72%/0.65%)、磷(0.95%/0.80%;1.43%/0.84%)、胆固醇(1.49%/1.58%;2.17%/1.80%)、总蛋白(0.84%/0.75%;1.60%/1.68%)、白蛋白(1.33%/2.28%;1.94%/2.43%)、谷丙转氨酶(1.41%/0.51%;3.24%/1.60%)、γ-谷氨酰氨基转移酶(1.16%/1.16%;2.85%/2.49%)、谷草转氨酶(4.37%/2.14%;2.99%/1.31%)、乳酸脱氢酶(2.70%/2.54%;3.84%/2.97%)、碱性磷酸酶(2.63%/1.96%;2.31%/2.10%)、淀粉酶(0.95%/2.19%;1.58%/1.38%)和葡萄糖(0.60%/0.48%;1.41%/1.55%),均符合临床生物化学检验常规项目分析质量指标(WS/T403-2012)内规定的CV%要求。Pretrol?生化非定值质控品与伯乐生化�ObjectiveTo evaluate the inter-bottle variations,stability in consumption and interchangeability of unassayed biochemistry serum controls.MethodsComparison between unassayed serum controls from a domestic"Pretrol?"and an international"Bio-Rad"manufacturer was conducted in department of laboratory,in May 2016,with Roche Cobas 8000,Roche Hitachi 7600 and Siemens 2400 modular analyzer.The inter-bottle variation was determined by monitoring the inter-batch variation of 10 bottles of control samples after eliminating the intra-batch variation from the same bottle.Stability in consumption was determined as the precision after 7 days storage under 2℃to 8℃or 30 days of storage under-20℃since reconstitution.The interchangeability was determined as the precisionbetween the controls from different manufacturers for the same test.ResultsThe inter-bottle imprecision of controls from domestic manufacturer for 13 biochemistry tests(CV concentration 1/CV concentration 2)were potassium(0.26%/0.42%),sodium(0.26%/0.21%),phosphorus(0.00%/0.62%),cholesterol(0.56%/0.54%),total protein(0.52%/0.33%),albumin(0.44%/2.00%),alanine aminotransferase(1.72%/0.57%),γ-glutamylaminotransferase(0.52%/0.62%),aspartate aminotransferase(3.10%/1.09%),lactate dehydrogenase(0.76%/0.91%),alkaline phosphatase(1.13%/0.97%),amylase(0.30%/0.39%)and glucose(0.00%/0.40%).The stability in consumption of the controls from the domestic manufacturer(CV concentration 1/CV concentration 2 under 2℃to 8℃storage;CV concentration 1/CV concentration 2 under-20℃storage)were potassium(1.06%/0.36%;0.74%/0.48%),sodium(0.49%/0.59%;0.72%/0.65%),phosphorus(0.95%/0.80%;1.43%/0.84%),cholesterol(1.49%/1.58%;2.17%/1.80%),total protein(0.84%/0.75%;1.60%/1.68%),albumin(1.33%/2.28%;1.94%/2.43%),alanine aminotransferase(1.41%/0.51%;3.24%/1.60%)γ-glutamylaminotransferase(1.16%/1.16%;2.85%/2.49%),aspartate aminotransferase(4.37%/2.14%;2.99%/1.31%),lactate dehydrogenase(2.70%/2.54%;3.84%/2.97%),alkaline phosphatase(2.63%/1.96%;2.31%/2.10%),amylase(0.95%/2.19%;1.58%/1.38%)and

关 键 词：质量控制 临床化学试验 诊断试验 常规 临床实验室技术 

分 类 号：R446.11[医药卫生—诊断学]